Propulsive drug delivery from a swallowable device into a patients intestinal tract

Abstract

Embodiments of the invention provide swallowable devices, preparations, and methods for delivering drugs and other therapeutic agents within the GI tract. Particular embodiments provide a swallowable device such as a capsule for delivering drugs or other therapeutic agents (TA) into a wall of the GI tract such as the stomach or small intestine. The swallowable device comprises a sensor, a combustible propellant (CP) and a therapeutic agent preparation (TAP) comprising at least one TA. The sensor triggers the CP to ignite and propel the TAP into the wall of the GI tract in response to an external condition or change in external condition. Embodiments of the invention are particularly useful for orally delivering drugs or other TAs which are degraded within the GI tract and require parenteral injection.

Description

CROSS-REFERENCES TO RELATED APPLICATION[0001]This application claims priority to, and the benefit of, U.S. Provisional Patent Application Ser. Nos. 62 / 821,250 filed on Mar. 20, 2019, and U.S. Provisional Application No. 62 / 812,867, filed on Mar. 1, 2019, the full disclosures of both of which are both incorporated herein by reference for all purposes.BACKGROUND1. Technical Field[0002]The present invention relates to swallowable drug delivery devices. More specifically, the present invention relates to swallowable drug delivery devices for delivering therapeutic agents into the gastric antrum or other portion of the stomach wall.2. Background Discussion[0003]While there has been an increasing development of new drugs in recent years for the treatment of a variety of diseases, many drugs including proteins, antibodies, peptides, and other labile medicaments have limited use because they cannot be given orally and thus typically require intravenous or other form of parenteral administra...

AI Technical Summary

Benefits of technology

The present invention is a swallowable drug delivery device that can deliver solid, liquid, gel, and powdered drugs and other therapeutic agents into the small intestine and other parts of the GI tract. The device has a tissue-penetrating member that can be designed to quickly release the drug or other therapeutic agent in the blood stream with minimal degradation in the stomach, small intestine, or other parts of the GI tract. The device can also contain a mixture of drugs for the treatment of multiple conditions or for the treatment of a particular condition. The invention addresses the issue of potential side effects from drugs by injecting the desired drug mixtures at about the same time, improving the pharmacokinetics and efficacy of the selected mixture of drugs.

Problems solved by technology

While there has been an increasing development of new drugs in recent years for the treatment of a variety of diseases, many drugs including proteins, antibodies, peptides, and other labile medicaments have limited use because they cannot be given orally and thus typically require intravenous or other form of parenteral administration (e.g., intramuscular, etc.) to avoid degradation.

The inability to deliver the drug orally may arise from any one of a number of reasons, including poor oral toleration with complications including gastric irritation and bleeding, breakdown / degradation of the drug compounds in the stomach, and poor, slow or erratic absorption of the drug.

Conventional alternative drug delivery methods such as intravenous and intramuscular delivery have a number of drawbacks including pain and risk of infection from a needle stick, requirements for the use of sterile technique and the requirement and associated risks of maintaining an IV line in a patient for an extended period of time.

While other drug delivery approaches have been employed such as implantable drug delivery pumps, these approaches require the semi-permanent implantation of a device and can still have many of the limitations of IV delivery.

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